US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for its drug Simponi (golimumab), seeking approval to treat children aged two years and older with moderately to severely active ulcerative colitis (UC).
Simponi’s FDA History and Approval in China
Simponi, an anti-TNF biologic medicine, received its initial FDA approval in April 2009. In December 2017, the drug was approved in China for the treatment of rheumatoid arthritis (when combined with methotrexate) and ankylosing spondylitis. Subsequently, in 2019, Simponi was included in China’s National Reimbursement Drug List (NRDL), making it more accessible to patients in the country.
Global Distribution Rights and Partnerships
Previously, in 2011, Merck, another US pharmaceutical major, signed a deal with Johnson & Johnson to obtain distribution rights for Simponi in markets outside of North America. This partnership highlights the global reach and recognition of Simponi as a treatment option for certain autoimmune conditions.-Fineline Info & Tech
